Enjoying „gluten free“ logos in your supermarket or on your favorite food products? An imminent European regulation on medical foods (2011/0156(COD)) threatens to turn into a government-granted monopoly on the use of „gluten free“ for the diet foods industry. If passed, regular gluten-free foods can no longer carry a „gluten free“ label. How did this happen and what can be done to prevent this?

Contents

Summary

1. The current proposal will make „gluten free“ disappear from regular food

The proposed new regulation forbids the use of the „gluten free“ marking on foodstuffs for normal consumption. The use of „gluten free“ will be reserved for „foodstuffs for particular nutrition uses“. To qualify for this, the product must not only meet the (unmodified) limit of 20 mg/kg gluten content, but the producer must now also implement a demanding quality assurance program. In addition, the regulation introduces a number of requirements that have nothing to do with the gluten content, such as the vitamin and mineral content and scientific and medical support for the entire composition. These new requirements will lead to considerable cost increases for „regular“ food producers wishing to place their products into this new category. If the proposal in its present form would be introduced, we may expect that the „gluten free“ designation will disappear from the majority of normal, gluten-free products. Click here for more details.

2. Commission mistake, wrong fix by European Parliament

If I am not mistaking, the problems started with the original proposal by the European Commission mentioning withdrawing the current gluten-regulation without creating any replacement rules in the new regulation. It is unclear to me why the Commission intended to withdraw the gluten-regulation in a regulation on food for infants, young children and medical purposes. The Italian Senate was quick to point out that withdrawal of the existing regulation was not desirable.

The European Parliament seems to have wanted to correct this mistake by copying certain parts of the existing regulation to the new regulation. However, in this process only the rules governing „gluten free“ for special foods were transferred, while the rules governing „gluten free“ for normal foods were not. It is difficult to know how this has come about within the parliament, because a compromise emerged early in the legislative process already. However, it seems the Italians and the Germans have been the main initiators. Having read the public sources, I get the impression that many MEPs were not aware of the consequences for consumer choice. Several MEPs stated that they preferred to have handled „gluten free“ differently, but still voted in favor of the entire package. Click here for more details.

3. Council and Parliament in complete disagreement; voice your opinion!

Both the Council of Ministers and the European Commission have advised against the inclusion of „gluten free“ in this regulation on special foods. They prefer to see the gluten-regulation merged into another regulation (Food Information to Consumers). That regulation applies to all foodstuffs. The Council will now negotiate about this matter with the Parliament. If I understand correctly, these negotiations are not public. Click here for more details.

Contact your MEP

There is a risk that the Council and the Parliament will reach another compromise in which „gluten free“ is used as a bargaining chip again. It is therefore important to make your voice heard in the Council of Ministers and the European Parliament. Find your member of the European Parliament at the bottom of this page and let him/her know your opinion! Click here to jump to the bottom of the page.

Commentary

New requirements „for protection“

Currently, the use of „gluten free“ is governed by Regulation (EC) 41/2009. This current regulation sets requirements for the gluten content only.

In the new proposed regulation, two new categories of requirements are introduced under the pretext of „protection of a vulnerable group“:

Additional requirements may give more certainty about a food’s gluten content, but may also create entry barriers for producers and lead to a reduced supply of gluten-free foodstuffs. Therefore, new requirements need to be considered with scrutiny.

„specially made for“ vs. „suitable for“

These additional requirements are meant to specify the „special composition or manufacturing process“ that, according to the definitions of this proposal, go with specialized nutrition „specially made for people intolerant to gluten“. The requirements are a further specification of the general requirement „specially made for„.

This is wrong from the beginning. „Specially made for“ is about the intent of the manufacturer. However, for the consumer the manufacturer’s intent is irrelevant. The consumer wants to know if the final product can be consumed or not. From the perspective of „people intolerant to gluten“ the focus should be on „foodstuffs suitable for people intolerant to gluten“.

For example: Your favorite supermarket carries a ready-meal that contains no gluten, is a good alternative to other ready-meals and fulfills your food needs. It is therefor foodstuff suitable for people intolerant to gluten. It has no special composition or manufacturing process and it is not made specially for them, but does that matter? The gluten-free consumer’s main concern is whether he can eat it or not.

GMP-requirement: Little assurance

Is it necessary and useful to protect the „gluten free“ marking with Good Manufacturing Practice (GMP), a quality control system? That depends on how things are going without GMP. Right now, the „gluten free“ mark can be used without use of GMP and it seems to me that manufacturers handle this responsibly enough. The food industry is subject to many quality controls already, in addition to the scrutiny of consumer groups and individual consumers. Moreover, even certification is no guarantee for flawless manufacturing. Should you give up a large part of your freedom of choice for a small increase in security? Especially considering that even a GMP-produced product is still allowed to contain a maximum of 20 mg/kg gluten. For those consumers that value certified quality control, one could also consider using a separate label, e.g. „gluten free extra assurance“.

Composition requirements: Patronizing

As long as ordinary consumers have the freedom to choose a balanced diet or not, this freedom should also be granted to gluten-free consumers. In the debates, people with gluten intolerance are constantly referred to as a „vulnerable group“, even though this group is also just a cross section of the general population. Helping people with gluten intolerance goes overboard when gluten-free consumers are forced to opt for a „balanced“ diet, compiled according to government specifications. Like the rest of the population, gluten-free consumers must be free to choose how „balanced“ their food pattern is themselves. The important issue is the absence of gluten, not the presence of other nutrients. Adult celiac patients do not need Liese (Germany, EPP) to know that eating gluten-free sweets all day is not healthy.

Besides, a distinction should be made between the different „vulnerable groups“. The original proposal of the European Commission saw upon infants, children and medical nutrition. In these cases, we are talking about young parents and acutely ill, groups that normally have a temporary need for special nutrition. They have little time and energy to search for information, are therefore more „vulnerable“ and need to be protected against food industry marketing. This does not apply to celiac disease patients. Celiacs need to adhere to a gluten-free diet their entire lives, giving them ample time to delve into the nutritional values of their gluten-free food choices. Many celiacs are members of celiac disease patient groups or exchange recipes and nutrition tips on the Internet. We may therefore expect that celiac patients are better informed consumers than young parents and acutely ill and therefore less in need of protection against the marketing of the food industry.

Regulating away competition

The statements made in the debate show that the interests of gluten-free specialized foods companies have played a role in this process. Now that many regular foodstuff producers have discovered the gluten-free consumer market (about 0.5 to 2% of the European population suffers from celiac disease), recent years must have brought increased competition for the producers of specialized nutrition. However, it is not the task of a government to provide chosen companies with an artificially increased market share. The increase in the use of the „gluten free“ designation in the supermarkets results from normal, open market economics and the EU does not need to protect the special foods industry from this.

Incidentally, there are still plenty of other opportunities for the specialized food industry. For products originally containing wheat flour as its main ingredient, such as bread, biscuits and pasta, still very few gluten-free own brand alternatives are available. The specialized foods industry needs to seize those opportunities instead of relying on the EU to regulate away competition.

Consumer interests must come first

The proposed criteria „special composition or manufacturing process“ and „specially made for“ seem written from the perspective of existing manufacturers in the special dietary foods market and not in the interest of consumers in that market, for whom it comes down to whether products are „suitable for“ them.

Looking from the perspective of the gluten-free consumer, it is clearly better to make no distinction between special and ordinary food, but to regulate ‚gluten free‘ at once for all foodstuffs instead. Several parties in the legislative process (the Commission, the Council, several members of the European Parliament) agree (see elsewhere in this article). Until this matter is resolved, the repeal of Regulation (EC) 41/2009 naturally needs to be postponed as well.

Reconsider the 20 mg/kg limit

Why is the 20 mg/kg limit not reconsidered instead? Even in the new proposal, a product with 15 mg/kg gluten content may be marketed as „gluten free“, despite patient forums swarming with patients claiming to experience symptoms from such low levels. One could consider a requirement that a product should have a theoretical gluten content of 0 mg/kg according to the recipe, while allowing outliers of up to 20 mg/kg in the final product to allow for possible traces of gluten in the production process.

Category „very low gluten content“ unneeded

Why not abolish the term „very low gluten“ (between 20 and 100 mg/kg gluten content)? An unneeded product category that I have never come across in any shop and that most celiac patients probably would not choose anyway.

Only gluten

Finally, it is puzzling that the European Parliament only adds gluten, while other illnesses and allergies are not mentioned. Diabetes and lactose intolerance are omitted for now, while peanuts, shellfish, etc. are completely ignored.

From compromise to compromise

Although it seems that the European Parliament is standing united behind this change, there are many signs that due to a series of negotiations, a certain belief has surfaced that is not necessarily shared by all MEPs. A reconstruction:

Subsequently, these German and Italian members appear to have won over group colleagues within their own fractions. Liese (Germany, EPP) mentions a long debate and a compromise on gluten in his group. Given the wide range of political backgrounds of the authors of the amendments, this German / Italian push must have influenced various parties simultaneously.

By the time the subject was tabled in the ENVI Committee, compromises had already been reached within each of the major political groups, resulting in closed ranks on the inclusion of „gluten free“.

A smaller party like the ECR opposed the gluten-proposal within the ENVI Committee. However, „gluten“ was only a minor part of a much larger proposal. When that entire proposal was up for vote, ECR voted in favor. See the later remarks made by Girling (United Kingdom, ECR).

Again, by the time the proposal was discussed in the plenary sitting of the European Parliament, it seemed as if the ENVI Committee stood united behind the inclusion of „gluten free“.

In the voting during the plenary sitting, most MEPs seem to have blindly followed the proposal from the ENVI Committee. During the debate and in the explanations of votes there was some grumbling, but for most there was not enough reason to vote against the entire proposal.

Time and again, nobody seems willing to make a breaking point out of this issue and so it goes from compromise to compromise. Through multiple steps of such back room decision making, a minority proposal can win a majority vote. Although it might seem that the entire European Parliament is firmly in favor of the proposal to include „gluten free“, in reality it was proposed by only a handful of Italian and German ENVI Committee members.

The debate and the explanations of votes show that many MEPs are eager to do ’something‘ for their celiac electorate. I hope that they will acknowledge that the current proposal is not that ’something‘ celiac patients are waiting for.

Suggestions for improvement

Completely undo all gluten-free-amendments, as tabled by the European Parliament in first reading; and

Delete article 17(2) (repeal of Regulation (EC) 41/2009) from the original proposal by the European Commission; and

Request the European Commission to make a new proposal on regulating „gluten free“ in a regulation that also applies on foods for normal consumption, e.g. Regulation (EU) 1169/2011.

Repair the current proposal as well as possible:

Add a new paragraph to Article 10a (4), containing the same text as Article 4 of Regulation (EC) 41/2009. In short: The term „gluten free“ may also be used on foodstuffs for normal consumption, provided that the gluten content does not exceed 20 mg/kg; and

Add another new paragraph to Article 10a (5), with the provision that, except for the requirement regarding the gluten content, other requirements of this regulation (including Article 9 and Article 10a(3)) do not apply to the foodstuffs for normal consumption as mentioned in the preceding paragraph.

Create a new marking:

Distinguish between „gluten free“ for gluten-free foods for normal consumption and „specialized nutrition for celiac disease patients“ for gluten-free specialized food, and

Optional: Eliminate the „very low gluten content“ category.

Contact your MEP

If you want to exert influence on the forthcoming negotiations between the Council and the European Parliament, you can contact an MEP. Below is an overview of all European political groups and members involved in this regulation.

If you would like to contact an MEP from your own country, check out this complete list of ENVI Committee members with their countries and political affiliation. You can also search MEPs by country, political group and/or committee membership. Click an MEP’s name to open a profile page with contact details.

I personally contacted MEP Esther de Lange (The Netherlands, EPP). She expresses that as far as she is concerned, there should be no changes in the everyday life of celiac patients. At the same time, she acknowledges that gluten-free products are put in jeopardy by the proposal in its current form. Although the margin for changes is limited, De Lange says she will try to cover this issue in the negotiations to be held with the Council, in which she will represent the EPP Group.

Let’s hope the industry is creative enough to find a way to keep on making our daily shopping easier for normal consumption food that does not contain gluten. No law against using some sort of icon that will be explained as free of wheat/barley/rye/etc